AMA Approves Category III CPT® Code for Innoblative's SIRA® RFA Electrosurgical Device, an Adjunct for Patients Undergoing Breast Conservation Surgery

• Assignment of CPT codes marks important milestone in path to commercialization and reimbursement in U.S.
• SIRA's novel circumferential design yields reproducible ablation depths across the entire cavity, aiming to reduce positive margin and reoperation rates

CHICAGO, March 3, 2026 /PRNewswire/ -- Innoblative Designs, Inc. (Innoblative), a private medical device company addressing clinical unmet needs for patients with breast cancer, announced today that it has received Category III Current Procedural Terminology (CPT^®) approval from the American Medical Association (AMA) for its SIRA^® device. The new code, approved for intraoperative radiofrequency ablation in patients with breast cancer, is expected to take effect in 2027 and will provide a formal mechanism to track real-world data on utilization, outcomes, and health economics.

"We are thrilled to have received AMA Category III approval, a strong signal of SIRA's clinical credibility and market readiness," stated Richard Stark, CEO of Innoblative. "This milestone establishes a critical foundation for broader clinical adoption, provides a standardized framework for evidence generation, and positions our technology for long-term reimbursement and commercial success."

Innoblative's SIRA device is a first-of-its-kind technology designed for intraoperative ablation of the post-lumpectomy cavity during breast conservation surgery (BCS). The unique spherical design delivers radiofrequency (RF) energy circumferentially, producing reproducible ablation depths across the entire cavity and providing greater confidence that the margins, where residual cancer may reside, have been ablated. The single-use, disposable applicator aims to reduce positive margin rates and BCS reoperations, with the goal of offering a one-time, non-ionizing therapeutic alternative to radiation therapy for patients, subject to further clinical validation, and with the long-term objective of reducing healthcare costs and improving patient care.

Breast cancer is a major global health concern, and once diagnosed, patients face difficult decisions regarding available treatment options.¹ Breast conservation therapy (BCT), which includes BCS plus radiation therapy, may be recommended. However, BCS is associated with a high reoperation rate, with approximately one in five patients requiring a follow-up procedure within weeks of the initial excision to address residual cancer.² In addition, subsequent radiation therapy often requires frequent treatments over several weeks or months and is commonly accompanied by a range of significant side effects. Innoblative aims to provide an alternative option that allows patients to avoid these concerns.

The SIRA^® device is investigational for use in BCS in the United States.

About Innoblative:

Innoblative is a medical device company dedicated to developing advanced energy solutions that improve how physicians treat breast cancer and other soft-tissue diseases. For more information, visit Innoblative.com.

¹Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID: 33538338.
²Kim Y, Ganduglia-Cazaban C, Tamirisa N, Lucci A, Krause TM. Contemporary Analysis of Reexcision and Conversion to Mastectomy Rates and Associated Healthcare Costs for Women Undergoing Breast-Conserving Surgery. Ann Surg Oncol. 2024 Jun;31(6):3649-3660. doi: 10.1245/s10434-024-14902-z. Epub 2024 Feb 6. Erratum in: Ann Surg Oncol. 2024 Jun;31(6):3956. doi: 10.1245/s10434-024-15212-0. PMID: 38319511; PMCID: PMC11076367.

Media Contact: 
Charlene Herndon
SPRIG Consulting
[email protected]

SOURCE Innoblative Designs, Inc.